French Observatory on the Management of Cardiogenic Shock in 2016 (FRENSHOCK)

August 13, 2019 updated by: French Cardiology Society

Cardiogenic shock (CS) is defined as an organ hypoperfusion secondary to low cardiac output. Catches diagnostic management, and therapeutic monitoring of these patients remain highly variable from one center to another and even from one doctor to another within the same team. The management protocols are often not standardized or non-existent.

It appears therefore necessary to make an inventory of the management practices of the CS in France in 2016, prerequisite to a common work of standardization of practices and the creation of specialized networks to support these complex patients.

Study Overview

Status

Completed

Conditions

Detailed Description

The Observatory FRENSHOCK proposes to set up a cohort of 500 patients recruited prospectively over a period of 6 months.

Patients will be followed up at 1 month and 1 year Patients should have agreed to participate in the observatory, knowing that participation or refusal to participate will not alter the therapeutic attitude of the physician responsible for the patient. The study of phenotypic characteristics will not change the therapeutic approach of the medical teams.

Study Type

Observational

Enrollment (Actual)

777

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patient (> 18 years) with cardiogenic shock table defined by the combination of a low cardiac output even as the filling pressures are normal or high, originally of hypoperfusion and suffering of organ.

Description

Inclusion Criteria:

  • Informed consent
  • Cardiogenic shock authenticated by the existence of at least one positive test for each of the following three parts:

(A) Low cardiac output (1 criterion necessary and sufficient):

  • Clinic: SBP <90mmHg and / or need to maintain inotropic or vasopressor to maintain SBP> 90 mmHg
  • Echocardiography: IC <2.2L / min / m2 and / or LVEF <30%
  • Hemodynamics by Swan Ganz catheterization or right: IC 2.2 l / min / m2 (B) elevation of pulmonary pressure / left surcharge (1 criterion necessary and sufficient):
  • Clinical (IVD and abortion);
  • Radiological (Surcharge on RT or chest CT);
  • Organic (NTproBNP> 900pg / ml or BNP> 400pg / ml);
  • Echocardiography (E / A> 2 if LVEF <45% or E / Ea> 13 if normal LVEF, or PAPS> 35mmHg and / or TDE <150ms and / or Ap-Am> 30ms and / or E / 2 Vp≥ , 5);
  • Right Swan Ganz catheterization or (pulmonary capillary pressures> 15mmHg and / or mPAP> 25mmHg)

(C) Organs malperfusion (1 criterion necessary and sufficient):

  • Clinic: oliguria <30ml / kg / h, mottling, consciousness disorders)
  • Organic: arterial lactate> 2 mmol / L, liver failure, kidney failure

Exclusion Criteria:

  • Final diagnosis retained other than cardiogenic shock
  • Cardiac arrest without spontaneous activity in the hospital management
  • Post-cardiotomy cardiogenic shock
  • Deprived of liberty patient
  • Refusal or lack of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cardiogenic shock
Patient with cardiogenic shock table defined by the combination of a low cardiac output even as the filling pressures are normal or high, originally of hypoperfusion and organ suffering.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at day 30
Time Frame: 30 days
Death rate at 30 days of follow-up
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of mortality at day 30 by subgroup on age, sex, NYHA grade, initial etiology
Time Frame: 30 days
Rate of mortality at day 30 distributed by subgroup on age, sex, NYHA grade, initial etiology (Including ischemic versus non-ischemic heart disease, type and assistance and medical treatment)
30 days
Mortality at 1 year
Time Frame: 1 year
Death rate at 1 year of follow-up
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Investigators

  • Principal Investigator: Clément DELMAS, AP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15897

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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